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This year the CDISC Glossary update included a more robust and frequently used request process for new terms because the Glossary activity was better integrated into the CDISC Controlled Terminology Team that supports the exchange of digital information. The Glossary seeks to eliminate semantic confusion in human information exchange and disambiguate the meaning of terms, acronyms, abbreviations, and initials used in the various foundational standards developed by CDISC for clinical research. The Glossary also serves as an educational resource for the clinical research community, by defining relevant terms pertaining to clinical research, including eClinical investigations, sponsored by the pharmaceutical industry or a federal agency. The team updated about 50 existing terms; reviewed close to 100 new terms that had been proposed; and updated or added more than 150 Acronyms/Abbreviations/Initials not included last year. In addition, sources for definitions from new guidelines are provided in the Glossary.xls format as a tab for ease of use.
Download Statistics for the Glossary publication files from the NCI FTP site from public review month to November
To complete the 2018 expansion of the published 2017 CDISC Glossary, the team met every week virtually; held a two-day face-to-face workshop of intensive team review and preparation of related-term clusters that would be useful to a user to consider as a group; and prepared the Glossary for annual public review in September. Terms that fit the new concept of definition “clusters” were monitoring, exposure, study participant/subject, investigator, just to give a few examples.
All formats of the updated Glossary, the Glossary directory, the New Term request form are available at:
CDISC Glossary Team members are:
Helle Gawrylewski as Lead, Guido Claes, and Denise Adelman (all Janssen R&D of J&J); Erin Muhlbradt (EVS in NCI/NIH); Art Gertel (MedSciCom); Stephen Raymond (ERT); Jon Hilton (F. Hoffmann-La Roche Ltd); Chris Gemma (CDISC); and Melissa Cook (MC Consulting).